Study of Stored Tumor Samples in Young Patients With Brain Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by St. Jude Children's Research Hospital
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00897286
First received: May 9, 2009
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

This laboratory study is looking at stored tumor samples in young patients with brain tumors. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.


Condition
Brain and Central Nervous System Tumors

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Molecular and Histopathologic Characterization of Atypical Teratoid Rhabdoid Tumors, Choroid Plexus Carcinomas, Ependymomas, Medulloblastoma/PNET and Gliomas of the Pediatric CNS

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Relationship between molecular abnormalities and tumor histologic and clinical characteristics [ Time Frame: 20 Years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Fresh frozen, fixed and cultured tumor cells collected prospectively from a clinically well characterized patient cohort.


Estimated Enrollment: 500
Study Start Date: November 2004
Estimated Study Completion Date: November 2024
Estimated Primary Completion Date: November 2024 (Final data collection date for primary outcome measure)
Groups/Cohorts
Tumor/Tissue Sample
Tumor material collected prospectively from a clinically well characterized patient cohort

Detailed Description:

The overall objective of this non-therapeutic protocol is to identify molecular abnormalities within prospectively treated pediatric CNS Atypical Teratoid Rhabdoid Tumors (ATRT), Choroid Plexus Carcinomas (CPC), Ependymoma and gliomas and define the relationship between these abnormalities and tumor histologic and clinical characteristics. This objective will be achieved by applying state-of-the-art DNA, RNA and protein analysis tools to the study of fresh frozen, fixed and cultured tumor cells. The establishment of cell cultures from each tumor sample will also allow for in vitro analysis of tumor cell growth, signaling and therapeutic response.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants will have ATRT, CPC, medulloblastoma/PNET, ependymoma or glioma of the CNS as documented by the local neuropathologist. All studies will be conducted using tumor material collected prospectively from a clinically well characterized patient cohort.

Criteria

Inclusion Criteria

  • ATRT, CPC, medulloblastoma/PNET, ependymoma or glioma of the CNS as documented by the local neuropathologist. Tumor may be primary, progressive or recurrent CNS tumor including brain and/or spine.
  • Age not more than 21 years at the time of initial diagnosis.
  • Enrollment in the current version of the institution's banking protocol

Exclusion Criteria

  • Diagnosis of tumor outside the central nervous system.
  • Age greater than 21 years at the time of diagnosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897286

Contacts
Contact: Tabatha E. Doyle, RN 901-595-2544 tabatha.doyle@stjude.org

Locations
United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Tabatha E. Doyle, RN    901-595-2544    tabatha.doyle@stjude.org   
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
Principal Investigator: Amar Gajjar, MD St. Jude Children's Research Hospital
Principal Investigator: Richard J. Gilbertson, MD, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00897286     History of Changes
Other Study ID Numbers: NBTP01
Study First Received: May 9, 2009
Last Updated: August 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Jude Children's Research Hospital:
childhood atypical teratoid/rhabdoid tumor
childhood choroid plexus tumor
childhood medulloblastoma
recurrent childhood medulloblastoma
childhood infratentorial ependymoma
childhood supratentorial ependymoma
recurrent childhood ependymoma
recurrent childhood supratentorial primitive neuroectodermal tumor
untreated childhood supratentorial primitive neuroectodermal tumor
gliomas

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Medulloblastoma
Neoplasms
Neoplasms by Site
Nervous System Diseases
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neuroectodermal Tumors, Primitive
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on October 19, 2014